|Publication number||US7758614 B2|
|Application number||US 10/117,576|
|Publication date||Jul 20, 2010|
|Priority date||Jul 8, 1998|
|Also published as||US20020173821|
|Publication number||10117576, 117576, US 7758614 B2, US 7758614B2, US-B2-7758614, US7758614 B2, US7758614B2|
|Inventors||Paul V. Fenton, Paul A. Westhaver|
|Original Assignee||Tornier, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (55), Referenced by (1), Classifications (14), Legal Events (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation in part of U.S. application Ser. No. 09/607,880, filed Jun. 30, 2000, (now U.S. Pat. No. 6,423,088 issued Jul. 7, 2002) which is a continuation in part of U.S. application Ser. No. 09/349,663, filed Jul. 8, 1999, (now U.S. Pat. No. 6,409,743 issued Jun. 6, 2002) which claims priority to provisional U.S. patent application Ser. Nos. 60/092,072 and 60/092,074, both filed Jul. 8, 1998. Each of these four applications are hereby incorporated by reference into this application.
The present invention relates generally to devices and methods for securing a suture(s) without knots, and for securing living tissue structures together without knotted sutures.
In minimally invasive surgical procedures that use elongated instruments and videoscopic viewing of the surgery site, there is significant difficulty in knot tying and wound approximating. Traditional methods of wound closure routinely involve the use of individual hand-knotted sutures. The suture strands are directed through portions of tissue to be joined and formed into a single stitch, which is then knotted. However, due to the location of the area being sutured, the delicate nature of anatomical features, and the stiffness of the suture used, it can be difficult to tie uniform stitches to close the wound that do not unravel or tie off (or ligate) a vessel. Non-uniform stitches (i.e., stitches of varying tension) or varied bite size (depth into the tissue) can cause uneven healing, localized trauma, infection, and patient discomfort.
To reduce the discomfort and aid healing, it is desirable to secure sutures uniformly and close to a wound. Due to the stiffness of some sutures, knotting the sutures can be difficult, particularly when the tissue to be sutured is deep within the body. Typical knots may be relatively large and elevated above the tissue being sutured, which can increase patient discomfort.
It is also desirable in many surgical procedures where sutures are used, to reduce the size of, or eliminate, the knot bundle associated with a knotted suture and to minimize the amount of foreign material in the body. The knot bundle can become an irritant and retard the healing process and cause discomfort or pain for the patient. The knot bundle can also be a source of infection.
Methods known in the art to overcome these problems include various suture securing devices such as buttons, and methods of fusing synthetic sutures. Although buttons can produce sutures with even tension and without the concomitant dexterity of knot tying, their elevated location above the wound or within the body cavity can cause irritation and discomfort. Furthermore, there is a risk of button migration, since they are discrete objects in the body.
Suture fusion techniques, whereby synthetic polymer suture strands are melted together by the application of heat or other energy to the sutures, are known in the art. Examples of devices to perform such suture fusion are disclosed in U.S. Pat. No. 5,417,700, assigned to the assignee of this application and incorporated herein by reference. However, some polymeric sutures are not amenable to this process. For example, braided or multi-filament sutures may not completely fuse since spaces between the individual strands may interfere with the heat or energy transfer needed for fusion to occur. As a result, the sutures may be incompletely fused, and the resulting joint may fail.
It would be advantageous to provide suture and tissue joining devices which are fusible to and/or around sutures and other structures, including living tissue, so as to avoid the need for suture knots.
According to one aspect of the invention, there is provided a closed suture loop formed from one or more elongated members or the same elongated member looped upon itself. The closed suture loop includes a fusible open or U-shaped coupling member that is disposed about an open interior region which extends about a central axis. A fusible inner surface of the coupling member defines the open interior region.
In one embodiment, the elongated members are surgical sutures which are made of a fusible material. End portions of the sutures are adapted to fuse to each other and also to the interior surface of the coupling member in a knotless weld upon application of sufficient energy to the end portions and the coupling member.
In another embodiment, the sutures are made of non-fusible, or minimally fusible material and only the interior surface of the coupling member is fusible so that upon an application of energy, the sutures are depressed into softened portions of the interior surface. In another embodiment, the sutures are made of braided material that is marginally fusible. In another embodiment, the elongated member comprises a band of material that encircles a bundle of other structures, such as blood vessels, for example, for ligation.
The coupling member is preferably made of a thermoplastic polymeric material. The elongated members can be surgical sutures which are also made of a fusible, thermoplastic polymeric material. In another embodiment, the elongated members can be living tissue structures. The energy for fusing the members may be generated from a variety of sources known in the art, such as for example, thermal energy, optical energy, radio-frequency energy, current sources or more preferably, ultrasonic energy.
In another exemplary embodiment, the open or U-shaped coupling member includes one or more energy directors extending from an interior surface. The energy directors define fusion regions for the sutures and the coupling member and are adapted to focus applied energy to the fusion regions so that the sutures and coupling member fuse together preferentially at the fusion regions.
The inside surface of the coupling member may also be smooth, or have protrusions, grooves or other texturing to aid in securing the partially encircled structures.
According to another aspect of the present invention, there is provided a kit for forming knotless sutures or ligatures. The kit includes a fusible open or U-shaped coupling member as described above, and a fusing tool which positions the coupling member around end portions of the elongated member positioned in the interior region. The fusing tool applies energy to the end portions and the coupling member so that those end portions and the coupling member are mutually joined by fusion. The fusing tool includes generally an energy source, a welding head, an end effector, and general electronics, switches, control devices and the like for supplying weld energy and activating the end effector.
In one exemplary embodiment of the fusing tool, the energy source is ultrasonic energy, and the fusing tool includes an ultrasonic transducer, an ultrasonic welding horn, and an end effector. The end effector may include one or more jaw members adapted for selective deployment around at least a portion of the coupling member to form an ultrasonic welding anvil. In various embodiments, the end effector can be a pair of opposable jaws which move with respect to each other, or a pair of jaws which are resiliently biased toward each other.
In additional exemplary embodiments, energy for bonding is supplied by thermal energy (e.g., heat), optical energy (e.g., laser generated), electrical energy (e.g., radio frequency, RF), or current sources (e.g., resistive heating).
According to another aspect of the present invention, there is provided a kit for joining a plurality of surgical sutures together without a knot. The kit provides a fusible coupling member as described above and a fusing tool as described above. The fusing tool is for biasing end portions of sutures toward the interior surface of the coupling member, and applying fusion energy so that the suture end portions are securely retained to the coupling member.
For a fuller understanding of the nature and objects of the present invention, reference should be made to the following detailed description taken in connection with the accompanying drawings, in which:
Like features in the figures are labeled with like reference characters.
Depending on the selection of materials for the coupling member 51 and the suture 14, fusion can occur in selected regions, i.e., interface regions 54 a between the coupling member 51 and the suture 14, and at interface regions 54 b between the end portions 13 of the suture 14. The coupling member 51 is preferably made of a biocompatible material which in some forms of the invention, is sufficiently flexible to allow for moderate deformation of the coupling member 51 to allow the suture 14 (or anatomical structures) to be securely placed within the interior region 53. In one form, the material is resilient so as to retain the structures within the coupling member 51 and create contact surfaces for fused interface regions. Any type of material that meets these requirements can be used.
The coupling member 51 material is also capable of being fused or joined to the suture 14 material upon the application of energy, such as thermal energy (heat), optical energy (laser generated), electrical energy (radio frequency, RF), current sources (resistive heating), or preferably ultrasonic energy, to the coupling member. Preferred materials are synthetic polymers capable of being repeatedly softened or melted with the application of heat or pressure (commonly known as thermoplastics). Thermosetting plastics and other heat-fusible materials may also be suitable for use as a coupling member 51 under certain conditions. The coupling member 51 can be made by methods known in the art, such as, but not limited to, machining, injection molding, extrusion, thermoforming and the like.
If desired, the coupling member 51 can be made of a first material and the suture made of a second material having a melting temperature different from the first material, so as to further direct the melting and fusing upon the application of energy to the coupling member 51. Higher melting point materials may be preferred for the coupling member 51, particularly if a braided or multi-filament suture 14 is used, as the bonding energy can fuse underlying fibers as well as the suture itself. The energy required to melt the material using the various processes and the time required for the molten material to resolidify are well known in the art.
The suture 14 can be of any type customarily used for surgery, such as silk, but preferred materials are polymers such as PTFE, and especially preferred material are thermoplastics, such as polyamide (nylon), polypropylene, polyester, polyglycolic acid (PGA), polyglyconate, and polydioxanone. The suture 14 can be either substantially monofilamentous, multiple stranded, twisted, braided, or otherwise interlinked material. Filament of the suture 14 can have any cross-sectional shape, such as substantially circular, elliptical or rectangular.
The choice of materials for the suture 14 and the coupling member 51, and the geometry of the coupling member 51 and the suture determines where fusing occurs. For example, if the coupling member 51 and the suture 14 are made from materials with largely differing melting temperatures (e.g., if the coupling member 51 is a thermoset polymer and the suture is a thermoplastic polymer), the bonds occur at the suture to suture interface 54 b (and within the individual fibers that make up the suture in the case of a multi filament or braided suture), but little or no fusing occurs at the interface 54 a between the suture 14 and the coupling member 51. Conversely, when the coupling member 51 is made of a thermoplastic material and the suture 14 is made of a thermoset polymer, or when an anatomical feature is within the coupling member 51, fusing of the coupling member 51 to itself occurs at any overlap areas. This could be beneficial for retaining ligaments, vessels or ducts, while allowing the coupling member 51 to move relative to the ligaments, vessels or ducts retained therein, or for ligating a vessel or duct. In a most preferred embodiment, however, the coupling member 51 and the suture 14 are both made of a material(s) that melts at about the same temperature (e.g., both are made of thermoplastic polymers). Using the same material allows for bonds to occur at all or any of the contact interfaces 54 a, 54 b described above.
The interior region 53 of the U-shaped coupling member 51 is large enough to permit the end portions 13 of the suture 14 (or tissue structures) to be secured therein. As shown in
An exemplary embodiment of a fusing tool 30 constructed in accordance with the present invention is shown in
The fusing tool 20 and the coupling member 51 or a plurality of the coupling members 51 can be provided as a kit. The kit may also include various end effectors 24 that are interchangeable on the tool shaft 22 for accommodating different coupling member 51 shapes and sizes.
In addition, flattened or rounded ends 32 on the prongs 26 allow for the tip to abut living tissue when the end portions 13 of the suture 14 are pulled tight through the coupling member 51, such as at a wound site, thereby minimizing any gaps in the tissue to be joined and maintaining a desired tension on the suture 14. In one embodiment, the prongs 26 can also function as an anvil. In other embodiments, underlying bone, tissue, anatomical features, or other materials temporarily or permanently placed under the effector 25 may also act as an anvil. The latter design may be preferable if it is necessary or otherwise advantageous to secure the coupling member 51 as closely as possible to tissue so as to permit minimal gapping between the joined suture 14 and the coupling member 51.
The disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the disclosure being indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of the equivalency of the claims are therefore intended to be embraced therein
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US1822330||Jan 13, 1930||Sep 8, 1931||George Ainslie||Suturing instrument|
|US2336689||Jun 17, 1941||Dec 14, 1943||Singer Mfg Co||Surgical needle|
|US2461030 *||Mar 6, 1945||Feb 8, 1949||American Steel & Wire Co||Method of making torpedo nets|
|US3113408||Dec 3, 1959||Dec 10, 1963||Grace W R & Co||Process for securing a shrinkable fastener to a container|
|US3407777||Apr 25, 1967||Oct 29, 1968||Navy Usa||Fairing support ring|
|US3462803||Apr 22, 1968||Aug 26, 1969||Branson Instr||Fastener for holding flexible sheet material and method for retaining such material|
|US3503119||Dec 22, 1967||Mar 31, 1970||Amp Inc||Method for applying a closure device to an end of a flexible container|
|US3513848||Dec 11, 1967||May 26, 1970||Ultrasonic Systems||Ultrasonic suturing|
|US3516631||Jul 28, 1969||Jun 23, 1970||Kenneth E Santucci||Cable clamp|
|US3608539||Nov 6, 1968||Sep 28, 1971||Miller Daniel G||Method for the biopsy of subcutaneous masses|
|US3664345||Jul 6, 1970||May 23, 1972||Clyde Harwell Dabbs||Surgical buttons|
|US3802438||Mar 31, 1972||Apr 9, 1974||Technibiotics||Surgical instrument|
|US3857396||Aug 22, 1973||Dec 31, 1974||C Hardwick||Suture clamp|
|US3879981||May 23, 1973||Apr 29, 1975||Richards Joseph E||Fishline connector device|
|US3995870||Nov 28, 1975||Dec 7, 1976||Anton Hulek||Process of manufacturing wrought-iron lattices|
|US4050100||May 12, 1976||Sep 27, 1977||Barry Robert J||Permanently implanted hair piece attaching means|
|US4265246||May 30, 1979||May 5, 1981||Barry Cosmetic Suture Company, Inc.||Sterile cosmetic suture and scalp implant for attaching hair pieces|
|US4291698||Nov 28, 1979||Sep 29, 1981||Intermedicat Gmbh||Button for surgical applications|
|US4312337||Sep 8, 1980||Jan 26, 1982||Donohue Brian T||Cannula and drill guide apparatus|
|US4369787||Oct 30, 1980||Jan 25, 1983||Laschal Instruments Corp.||Method of cutting a suture|
|US4561153||Nov 1, 1983||Dec 31, 1985||Kitagawa Industries Co., Ltd.||Cable clamp|
|US4583540||Mar 30, 1981||Apr 22, 1986||Hills Family Preservation Trust||Hair replacement apparatus|
|US4588408||Sep 15, 1982||May 13, 1986||Shiro Yamada||Treated hair for implantation|
|US4590929||May 3, 1983||May 27, 1986||Klein Harvey A||Tools for orthopaedic surgery and the like|
|US4635638||Jan 29, 1985||Jan 13, 1987||Galil Advanced Technologies Ltd.||Power-driven gripping tool particularly useful as a suturing device|
|US4896668 *||Apr 9, 1987||Jan 30, 1990||Peters||Plate set for osteal fixation, equipped with suture strands|
|US4930502||Jan 26, 1989||Jun 5, 1990||Chen Fusen H||Anastomosis device|
|US4935027||Aug 21, 1989||Jun 19, 1990||Inbae Yoon||Surgical suture instrument with remotely controllable suture material advancement|
|US4957498||Nov 7, 1989||Sep 18, 1990||Concept, Inc.||Suturing instrument|
|US5078731||Jun 5, 1990||Jan 7, 1992||Hayhurst John O||Suture clip|
|US5356417||Oct 9, 1992||Oct 18, 1994||United States Surgical Corporation||Absorbable sternum closure buckle|
|US5376101||Dec 27, 1993||Dec 27, 1994||The United States Surgical Corporation||Suture retaining clip|
|US5383883||Jun 7, 1992||Jan 24, 1995||Wilk; Peter J.||Method for ultrasonically applying a surgical device|
|US5383905||Oct 9, 1992||Jan 24, 1995||United States Surgical Corporation||Suture loop locking device|
|US5391173||Feb 10, 1994||Feb 21, 1995||Wilk; Peter J.||Laparoscopic suturing technique and associated device|
|US5413585||Dec 22, 1992||May 9, 1995||Pagedas; Anthony C.||Self locking suture lock|
|US5417700||Mar 25, 1993||May 23, 1995||Thomas D. Egan||Automatic suturing and ligating device|
|US5425489||Feb 9, 1994||Jun 20, 1995||United States Surgical Corporation||Fascia clip and instrument|
|US5437685||Mar 30, 1994||Aug 1, 1995||Blasnik; William||Sternum banding assembly|
|US5500018||Mar 8, 1994||Mar 19, 1996||Protek Ag||Sealing element in the form of a strap|
|US5527341||Aug 30, 1994||Jun 18, 1996||Synthes (U.S.A)||Resorbable tendon and bone augmentation device|
|US5586983||Jan 31, 1994||Dec 24, 1996||Sanders; Albert E.||Bone clamp of shape memory material|
|US5593425||May 30, 1995||Jan 14, 1997||Peter M. Bonutti||Surgical devices assembled using heat bonable materials|
|US5611801 *||Nov 29, 1994||Mar 18, 1997||Pioneer Laboratories, Inc.||Method and apparatus for bone fracture fixation|
|US5618311||Sep 28, 1994||Apr 8, 1997||Gryskiewicz; Joseph M.||Surgical subcuticular fastener system|
|US5643289||Aug 16, 1995||Jul 1, 1997||Lasersurge, Inc.||Surgical crimping device and method of use|
|US5732530||Apr 4, 1997||Mar 31, 1998||Pfaff; Kathleen Sue||Method of sealing a balloon after it is inflated|
|US5735877||Feb 28, 1996||Apr 7, 1998||Pagedas; Anthony C.||Self locking suture lock|
|US5766218||Oct 1, 1996||Jun 16, 1998||Metamorphic Surgical Devices, Inc.||Surgical binding device and method of using same|
|US5769894||Feb 5, 1997||Jun 23, 1998||Smith & Nephew, Inc.||Graft attachment device and method of attachment|
|US5881452||Nov 5, 1997||Mar 16, 1999||Nowell, Iii; Stephen C.||Apparatus for applying deformable metal fastener clips to concrete reinforcement steel and the like|
|US5893880||Aug 28, 1997||Apr 13, 1999||Axya Medical Inc.||Fused loop filamentous material|
|US5941901||Apr 16, 1998||Aug 24, 1999||Axya Medical, Inc.||Bondable expansion plug for soft tissue fixation|
|US6047708 *||Apr 16, 1999||Apr 11, 2000||Panel; Sherelle L.||Kit and process for creating a hair bun|
|US6174324 *||Jul 13, 1998||Jan 16, 2001||Axya Medical, Inc.||Suture guide and fastener|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US20110190815 *||Sep 8, 2009||Aug 4, 2011||Saliman Justin D||Knotless suture anchors|
|U.S. Classification||606/232, 156/73.2|
|International Classification||A61B17/06, A61B17/04, A61B17/00, A61B17/12|
|Cooperative Classification||A61B17/00491, A61B17/0487, A61B2017/0619, A61B17/12013, A61B2017/0488, A61B2017/0456, A61B2017/0454|
|Jul 22, 2002||AS||Assignment|
Owner name: AXYA MEDICAL, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:FENTON, PAUL V. JR.;WESTHAVER, PAUL A.;REEL/FRAME:013103/0873
Effective date: 20020708
|Oct 14, 2009||AS||Assignment|
Owner name: AXYA HOLDINGS, INC., MINNESOTA
Free format text: MERGER;ASSIGNOR:AXYA MEDICAL, INC.;REEL/FRAME:023371/0671
Effective date: 20080725
Owner name: TORNIER, INC., MINNESOTA
Free format text: MERGER;ASSIGNOR:AXYA HOLDINGS, INC.;REEL/FRAME:023371/0680
Effective date: 20080725
|Oct 4, 2012||AS||Assignment|
Owner name: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT, CA
Free format text: PATENT SECURITY AGREEMENT;ASSIGNOR:TORNIER, INC.;REEL/FRAME:029076/0361
Effective date: 20121004
|Feb 28, 2014||REMI||Maintenance fee reminder mailed|
|Jul 20, 2014||LAPS||Lapse for failure to pay maintenance fees|
|Sep 9, 2014||FP||Expired due to failure to pay maintenance fee|
Effective date: 20140720
|Oct 20, 2015||AS||Assignment|
Owner name: TORNIER, INC., MINNESOTA
Free format text: TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS;ASSIGNOR:BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT;REEL/FRAME:036900/0672
Effective date: 20151001